US authorizes third injection of Covid vaccine for immunosuppressed

US regulators say transplant recipients and others with severely weakened immune systems may receive an additional dose of Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to rise.

Thursday night’s announcement by the Food and Drug Administration applies to several million Americans who are especially vulnerable due to organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.

It’s harder for vaccines to boost an immune system suppressed by certain drugs and diseases, so those patients don’t always get the same protection as otherwise healthy people, and small studies suggest that, for some at least, an extra dose may be the solution.

“Today’s action allows clinicians to boost immunity in certain immunosuppressed individuals who need additional protection against COVID-19,” FDA Acting Commissioner Dr. Janet Woodcock said in a statement.

The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the Pfizer and Moderna vaccines at least 28 days after receiving their second injection. The FDA did not list immunosuppressed patients who received the single-dose Johnson & Johnson vaccine.

The announcement comes as the extra-contagious delta version of the coronavirus spreads across much of the country, leading to new cases, hospitalizations and deaths at levels not seen since last winter.

Importantly, the FDA’s decision only applies to this high-risk group, estimated at no more than 3% of American adults. It is not an opportunity for booster doses for the general population.

Instead, health authorities consider the extra dose as part of the initial prescription for the immunosuppressed. For example, France since April has encouraged these patients to receive a third dose four weeks after their second regular injection. Israel and Germany also recently began recommending a third dose of two-dose vaccines.

Moreover, US health officials continue to closely monitor whether the immunity of the average person drops enough to require boosters for everyone, but for now, vaccines continue to offer robust protection for the general population. .

The Centers for Disease Control and Prevention is expected to formally recommend additional vaccines for certain immunosuppressed groups after a meeting of its external advisers on Friday.

Transplant recipients and others with weakened immune systems know they are at higher risk than the average American, and some have been seeking additional doses on their own, even if it means lying about their vaccination status. The change means that now high-risk groups can more easily be given another chance, but experts caution that it is not yet clear exactly who should do it.

“This is all going to be very personalized,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is conducting a major National Institutes of Health study of additional vaccines for organ recipients. For some people, a third dose “increases their immune response. However, for some people it does not seem to be the case. We still don’t know who is who. “

A recent study of more than 650 transplant recipients found that just over half harbored antibodies that fight the virus after two doses of the Pfizer or Moderna vaccines, though generally fewer than in otherwise healthy vaccinated people. Another study of people with rheumatoid arthritis and similar autoimmune diseases found that only those using particular medications have very poor vaccine responses.

There is little data on how well a third dose works and if it causes any safety concerns, such as an increased risk of organ rejection. On Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they received a third dose than those who received a sham injection for comparison. Other small studies have similarly found that some transplant recipients respond to a third dose, while others still lack sufficient protection.

(AP)

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